Facility

VOLK OPTICAL INC.

4 recall(s) on record — most severe on record: Class III.

Key facts

4recalls · worst Class III

1inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	1000122772
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	7893 ENTERPRISE DR. Mentor, OH, US 44060
Registration status	Active · expires 2026
Parent company	VOLK OPTICAL INC. (owner-operator 9000705)
Brand names	Pictor Worstation Pro (VPWSTNP); Pictor Workstation (VPWSTNL)

Activity by year

Recalls (4)
Inspections (1)

Devices registered here (1)

(unnamed device)
Product code NSX (opens in a new tab)

Recalls & enforcement

Class IIITerminated2016-02-02
The firm discovered that the incorrect lot number was engraved on the product.
Class IIITerminated2015-02-27
Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring.
Class IIITerminated2015-02-27
Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. The correct lot number is BE03356; however, BD03356 was engraved on the ring in error.
Class IIITerminated2012-10-25
The defect was with mis-engraving of the lot # directly on the product and its packaging. Mixed up device engraving of V20LC (lot # BB09213) with that from V60C (lot # BB09205).

FDA inspections (1)

VAI2017-09-28
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by VOLK OPTICAL INC.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “VOLK OPTICAL INC. (FEI 1000122772) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000122772-volk-optical-inc/

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